Title: Serial Release - Audits and Reference Slips for IC Documents
Release Date: 07 Jan 2021 Author: RSCHNURR Document Number: CVB-WI-0104.02
CONTROLLED//PROPIN//BASIC

2. Examples of Audit Reasons for APHIS Form 2008s

a. The form is incomplete or used the APHIS Form 2008 for the second page instead of the
APHIS Form 2008a.

b. The attached test summary identification does not match the information submitted via
the NCAH Portal.

c. A test conclusion is listed as a No Test but is actually an Inconclusive. (This may also be
done via a reference slip.)

d. Validation criteria listed in the OP not included on the APHIS Form 2008.

e. Incorrect information

f. Serial is expired

3. Examples of Audit Reasons for Export Documents

a. At primary review by the EDE
i. The Export Certificate, (APHIS Form 2017), does not list the correct dose size or the
document exceeds inventory released.
ii. The serial listed on the Export Certificate (APHIS Form 2017) is not released.

iii. The Export Certificate lists products from multiple establishments.

iv. Inconsistent details from the header of pages of the submitted Certificate of Licensing
and Inspection (different addresses and/or different codes).

v. The Certificate of Licensing and Inspection submitted is two sided.

vi. The product license listed on the Certificate of Licensing and Inspection is not active.
Exceptions can be made for current inventory of firms participating in a merger.

vii. Pages appended to the Certificate of Licensing and Inspection do not list the page x of
y format, the product code, label number (when applicable) and/or establishment
number.

viii. Incorrect/Unofficial form used.
ix. Firm employees signed the block for the certifying official.

b. Example of Audit reasons by Export Manager during Secondary Review

i. Information other than country of destination next to the USDA Official signature
block (Certificates of Licensing and Inspection) without prior authorization.

ii. The Export Certificate is from a product restricted to a specific recipient (FFM).

iii. The Export Certificate does not list the country destination.
iv. The discrepancy is verified by official hard-copy documents in the file room or on the
CVB SharePoint site.

v. The gmp-like statement deviates from the examples provided or is not listed in the
outline of production. The gmp-like statements which only reference the firm may be
submitted as stand-alone documents.

vi. An APHIS Form 2008 was appended to the Certificate of Licensing and Inspection
(APHIS Forms 2046, 2046-S, 2047, or 2047-S).
vii. Incorrect establishment or product license date used.
viii. True name is incorrect or is not presented as it is on the product license.
ix. The information submitted in not available on file.
x. The information provided in special labels do not list the disclaimer.

CVB-WI-0104.02 Page 4 of 6

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Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100


Title: Serial Release - Audits and Reference Slips for |C Documents
Release Date: 07 Jan 2021 Author: RSCHNURR Document Number: CVB-WI-0104.02
CONTROLLED//PROPIN//BASIC

4. Return to Firm
a. Ifthe record will be returned via the NCAH Portal, no further action is needed.
b. Ifthe records will be returned hard copy (note — all export documents are currently

returned hard copy) follow the following instructions:

For APHIS Form 2008s

Reference Slip Actions

Action Employee Timestamp RefSlipReason To Address Remarks
Reference Sip Added Watson, Jeanette 2016-01-22 03:41:08.0 Action test POF EDIT

i. Under the Attachment category, choose the Reference Slip hyperlink
ii. Open the attachment as a pdf and print
iii, Attach to hard copy APHIS Form 2008

For Certificates

Attachments

Add Attachment To Certificate
RetSlip_08/11/2016

iv. Print and sign a copy of the reference slip and attach it to the certificate.

5. Since reference slips may be added at any step and this does not stop the process, the
submission must be moved forward through the system.

B. Audits

Audits may be created by the Specialist, BCA, or EDE. Once an audit is created, the process is
ended. The authority to audit at each action is based on why the audit is being done. Some audits
created by the BCA or EDE must be reviewed by the Specialist or Export Manager prior to
finalization.

1. Authorities

Specialist/Export
Reason for Audit BCA/EDE Manager
Expired Reference Yes Yes
Inadvertent NCAH Portal entry Yes Yes
Incomplete Form Yes Yes
Info Does Not Reflect OP Yes — needs Specialist Review | Yes
Invalid Establishment Yes Yes
Invalid Expiration Date Yes Yes
Invalid Product Number Yes Yes
Previously Released/Processed by APHIS | Yes Yes
Product Under Regulatory Action No Yes
Request for Data No Yes
Serial not Released by APHIS Yes Yes
CVB-WI-0104.02 Page 3 of 6

Printed by: CRHERR on 11 Jan 2021, 04:49:11 pm.
Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100


Title: Serial Release - Audits and Reference Slips for |C Documents
Release Date: 07 Jan 2021 Author: RSCHNURR Document Number: CVB-WI-0104.02
CONTROLLED//PROPIN//BASIC

4. Audit Process

a. Audits can be added to APHIS Form 2008s at each tab in the Serial Action Sheet (except
for Product Manager Review and Misc.). It is found on the tab for each Action. If there is
already an Audit, the area will be blank.

APHIS:

Est Product Serial # e
ss = eposition

‘otner- UNSATISFACTORY Bases on Fims Resute AOR Reference Sip Specialist Review 2008) Sera Stat
Aut

Ava
Not bbe Tested ‘Audit Reference Sip Specialist Review 2008 Serial Stat
Nottpbe Testes TestReport AWS Reference Sip Specialist Review 2008/ Serial Stat

i. Choose the Audit Reason from the List of Values (LOVs) (mandatory field).

Note: The default for this field is “Expired Reference.”

ii. Signature (automatically filled in by user logged in)

iii. Comments — free field text for the user to enter information that they want relayed
back to the establishment — limit of 499 characters.
Note: This wording goes directly back to the manufacturer.

iv. Once audited, the Form 2008 will move to BCA Ready for Approval.

v. The system sends the Audit and APHIS Form 2008 back to the firm after the 2008
record is signed.

vi. Ifthe 2008 was submitted hard copy, the audit should be printed and signed as well.

b. Audits can be added to Export documents for a specific record at any action during the
review and finalization process. The reference slip is found on the individual certificate
record.

Action History

Action Employee Timestamp Info
Initial Creation Mattocks, David 2015-09.
Primary Reviewed attocks, David 2015-10-08 08:41:38.0

4 Edit wv Secondary Review # Audit Reference Slip

i. Choose the product to audit — the list of product codes available will be in the drop
down.
ii. Audit Reason from the List of Values (LOVs) (mandatory field).
Note: The default for this field is “Expired Reference.”
iii. Signature (automatically filled in by user logged in)
iv. Comments — free field text for the user to enter information that they want relayed
back to the establishment — limit of 499 characters.

CVB-WI-0104.02 Page 5 of 6

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Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100


Title: Serial Release - Audits and Reference Slips for |C Documents

Release Date: 07 Jan 2021 Author: RSCHNURR Document Number: CVB-WI-0104.02

Health Inspection
Service

Veterinary Services

Center for Veterinary
Biologics

1920 Dayton Avenue
PO Box 844
Ames, IA 50010

(15) 337-6100

CONTROLLED//PROPIN//BASIC

Serial Release - Audits and Reference Slips for IC Documents

Document Number: CVB-WI-0104 Revision: 02
Previous Number: ICWI0075.01

Vault: CVB-Released

Section/Area: CVB-WI-IC

Effective Date: 07 Jan 2021

Notes:

Printed by: CRHERR on 11 Jan 2021, 04:49:11 pm.
Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100


Title: Serial Release - Audits and Reference Slips for IC Documents
Release Date: 07 Jan 2021 Author: RSCHNURR Document Number: CVB-WI-0104.02
CONTROLLED//PROPIN//BASIC

Note: This wording goes directly back to the manufacturer.
v. Once audited, Certificate will have a finalize button at the bottom of the page. This

action will finalize the certificate.

Audit Actions

Action Employee Timestamp ‘Audit Reason Audit Comments
Audited ‘Schnurr, Renee 2016-08-11 13:48:49.0, Info Does Not Reflect OP TESTING PDF EDIT

C e Reference Slip

5. Return to Firm

a. Ifthe record will be returned via the NCAH Portal, no further action is needed, no hard
copy is needed, but the Step 5.b.iii. must be followed.

b. Ifthe records will be returned hard copy follow the following instructions:

For APHIS Form 2008s — under BCA Ready for Approval

Audit Actions
Action Employee Timestamp Audit Reason Audit Comments
‘Aphis 2008 Auclted king, Aaron 2016-07-28 10:58:17.0 Exped Reference gbgbgbgbg POF EDIT

i. Under the Audit Actions, open PDF and print

ii. Attach to hard copy APHIS Form 2008

iii. Move forward to Ready for Signature — have auditor physically and electronically
sign the audit form.

For Certificates
Audit Actions
Action Employee Timestamp Audit Reason Audit Comments
Audited Schnurr, Renee 2016-08-11 16:33:00.0 Expired Reference TEST PDF EDIT

i. Print and sign a copy of the audit slip and attach it to the certificate (Hard Copy
Certificates.
ii. Update shipping information in LSRTIS.

If the submission was received through the NCAH Portal, finalize the certificate after
the audit and “Update Shipping” by indicating “Portal” in the list of options.
CVB-WI-0104.02 Page 6 of 6

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Title: Serial Release - Audits and Reference Slips for |C Documents
Release Date: 07 Jan 2021 Author: RSCHNURR Document Number: CVB-WI-0104.02
CONTROLLED//PROPIN//BASIC

Audits and Reference Slips for IC Documents

Source Documents: CVB-SOP-0032, Processing Serial Records, and CVB-SOP-0048, Export Documents and
Certificates of Licensing and Inspection

Specialists, Biologics Compliance Assistants (BCA), and Export Document Examiners (EDE)
may attach reference slips to outgoing documents or audit documents back prior to completion.
The documents included in these processes are:

Veterinary Biologics Production and Test Report (APHIS Forms 2008 and 2008a)
Official Export Certificate for Animal Biological Products (APHIS Form 2017)
Certificate of Licensing and Inspection (APHIS Forms 2046, 2046-S, 2047, and 2047-S)
Attestations (GMP-Like certificates)

Ingredients of Animal Origin (Certificates indicating policies of ingredients of animal
origin)

A reference slip is used to communicate information back to the submitter without interfering
with the completion of the record. There are only two reasons used for a reference slip.

Reason for Reference Example of When to Use__2008s__Certificates

OP should be updated per
Action letter from Reviewer Yes Yes
For Information To clarify expectations Yes Yes

There are many other reasons listed in the drop down, but should not be used as a reference slip
for APHIS Form 2008s or Export Documentation.

An Audit stops the IC process. There may be many reasons a document process is interrupted.

Reason for Audit 2008s Certificates

Expired Reference Yes No
Inadvertent NCAH Portal entry Yes No
Incomplete Form Yes Yes
Information Does Not Reflect OP Yes Yes
Invalid Establishment Yes Yes
Invalid Expiration Date Yes Yes - 2017s only
Invalid Product Number Yes Yes
Previously Released by APHIS Yes Maybe
Product Under Regulatory Action Yes Yes
Request for Data Yes Yes

Serial not Released by APHIS Yes Yes - 2017s only

A. Reference Slips
A reference slip may be initiated by any Inspection and Compliance (IC) Program employee to

communicate specific information back to the submitter. A reference slip does not stop the IC
process and the record is completed.

CVB-WI-0104.02 Page | of 6

Printed by: CRHERR on 11 Jan 2021, 04:49:11 pm.
Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100


Title: Serial Release - Audits and Reference Slips for |C Documents
Release Date: 07 Jan 2021 Author: RSCHNURR Document Number: CVB-WI-0104.02
CONTROLLED//PROPIN//BASIC

1. Reference slips can be added to APHIS Form 2008s at each tab in the Serial Action Sheet
(except for Product Manager Review and Miscellaneous). It is found on the tab for each
Action. If there is already a reference slip, the area will be blank.

Specialist Review
Seanialist Revinw
‘Specialist Review

Showing 1 to 4 of 4 entries

2. Reference slips can be added to Export documents for a specific record at any action during
the review and finalization process. The reference slip is found on the individual certificate
record.

Action History

Action Employee Timestamp Info
Initial Creation Mattocks, David 2015-09-22 06:29:11.0
Primary Reviewed Mattocks, David 2015-10-08 08:41:38 0

7 Edit | v Secondary Review /Reference Slip

3. Reference slips (for both types of documents) are filled out in LSRTIS

a. Reason for reference slip — select from drop down

Reason for Reference Example of When to Use
Action OP should be updated per letter from Reviewer
For Information To clarify expectations

b. Signature (automatic)

c. Establishment Address — select from drop down or you can choose to add Free Form
Address — if you add Free Form Address, enter information in Address Line 1, 2, and 3
(as needed) and City, State, Zip

d. Establishment Employee — select from drop down or you can choose to add Free Form
Employee Name — if you add Free Form Employee Name, enter Employee Name

e. Remarks should include the Est. number, Product Code and Serial Number (if relevant).
This information does not print out on the reference slip automatically and will be used to
tie the reference slip to the correct submission. Also provide specific information for the
reason a reference slip is being created.

f. Click on Create Reference Slip

CVB-WI-0104.02 Page 2 of 6

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